Qualitative study exploring the experiences and perceptions of dolutegravir/lamivudine dual antiretroviral therapy (the PEDAL study) in people living with HIV: protocol

Giovanni Villa, Diego Garcia Rodriguez, David Fray, Amanda Clarke, Caroline Ackley, Giovanni Villa, Diego Garcia Rodriguez, David Fray, Amanda Clarke, Caroline Ackley

Abstract

Introduction: Antiretroviral treatment turned HIV infection into a chronic disease and improved quality of life for people living with HIV. Dual-drug combinations have been shown to be effective in suppressing viral replication and can potentially reduce long-term drug-associated toxicities. We aim to investigate patients' perceptions and experiences on the safety, effectiveness, tolerability and unmet needs of the dual-drug combination dolutegravir/lamivudine in Brighton and Hove, UK. In addition, we will conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other dual-drug and three-drug combinations. Finally, the study aims to provide recommendations to improve doctor-patient communication, knowledge and understanding of the treatment plan, and additional care that ought to be considered in patient-centred, holistic care plans.

Methods and analysis: Our qualitative methodological framework is based on three main methods: cultural domain analysis, focus group discussions and in-depth interviews. Cultural domain analysis employs a range of techniques (free listing, pile sorts and rankings) to elicit terms from informants regarding specific cultural domains (ie, groups of items that are perceived to be of the same kind). This framework has been codesigned with a patient representative to ensure relevance, suitability and coproduction of knowledge. All methods have been tested to take place online, as an option, via Zoom, Skype or Microsoft Teams. Padlet, an application to create online boards, will be used during the cultural domain analysis session. Data collected will be analysed following the completion of each method embracing an iterative approach through applied thematic analysis.

Ethics and dissemination: Ethical approval was obtained from the Health Research Authority (Reference 21/NW/0070). Findings will be used to produce recommendations to improve doctor and patient communication by identifying patients' fears, worries, misconceptions and general concerns of their drug regimen. Conclusions will be disseminated via journal articles, conference papers and discussions through public engagement events.

Project registration number: IRAS number: 286277. NCT04901728.

Keywords: anthropology; hiv & aids; qualitative research; therapeutics.

Conflict of interest statement

Competing interests: GV declares a research grant from ViiV Healthcare to his Institution to run the study presented in the manuscript; AC declares direct payments from Gilead Sciences, ViiV Healthcare, MSD, Theratechnologies for participation in advisory boards; a sponsorship from Gilead Sciences for conference attendance; research grants from Gilead Sciences, ViiV Healthcare, MSD to her Institution for running clinical trials. All the other authors have no competing interests to declare.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

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Figure 1
Comparison populations and target population.

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